10 September 2019 - - US-based biotechnology company Oncternal Therapeutics, Inc. (NASDAQ: ONCT) has appointed Gunnar Kaufmann, Ph.D., as chief scientific officer and Igor Bilinsky, Ph.D., as chief business officer, the company said.

Kaufmann, who has extensive experience in discovery and preclinical development of both biotherapeutics and small molecule drug product candidates, will focus on progressing Oncternal's preclinical product development programmes and exploring opportunities to expand the company's product development pipeline.

Prior to joining Oncternal, Kaufmann served as senior vice president, Immunotherapy, Head of Research and Global Partnerships at Sorrento Therapeutics, Inc.

Kaufmann was previously a faculty member at The Scripps Research Institute and still serves as Adjunct Assistant Professor in the Departments of Chemistry and Immunology and Microbial Science.

Kaufmann holds a B.S. in human biology from Phillips University Marburg, an M.S. in human biology from Ernst-Moritz-Arndt University Greifswald, and a Ph.D. from The Scripps Research Institute's Biology Program.

Bilinsky, who has more than 20 years of experience as a senior executive and consultant to the biotechnology industry, will be responsible for strategic planning and advancing corporate and business development initiatives at Oncternal.

Bilinsky formerly served as chief operating officer of AmpliPhi Biosciences Corp., a biotechnology company developing targeted therapies for patients with life-threatening bacterial infections.

Previously, Bilinsky was general manager, Immuno-Oncology, and senior vice president, Special Operations and Research Operations, at Ignyta, Inc., a biotechnology company focused on precision medicine in oncology that was acquired by Roche.

Prior to joining Ignyta, Bilinsky was senior vice president, Corporate Development at Vical Inc., vice president, business development and Special Operations at Halozyme Therapeutics, Inc., and chief executive officer of Androclus Therapeutics, Inc.

Bilinsky was previously a principal in the healthcare practice of the Boston Consulting Group, Inc., where he advised companies in the biotechnology and pharmaceutical industries on business strategy, operational performance, and mergers and acquisitions.

Bilinsky received his B.S. in physics from the Moscow Institute of Physics and Technology and his Ph.D. in physics from the Massachusetts Institute of Technology.

Cirmtuzumab is currently in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of chronic lymphocytic leukemia and mantle cell lymphoma, in a collaboration with the University of California San Diego School of Medicine and the California Institute for Regenerative Medicine.

In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with metastatic breast cancer is being conducted at the UC San Diego School of Medicine.

CIRM has also provided funding to support development programs for cirmtuzumab and a CAR-T product candidate that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors.

In August 2019, Oncternal announced it has opened for enrollment its randomized Phase 2 study of cirmtuzumab, a ROR1-targeted monoclonal antibody, combined with ibrutinib in patients with CLL.

The decision to open the Phase 2 portion of the company's ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial was triggered by favourable outcomes from the Part 1 dose-finding and Part 2 dose-confirming cohorts of the clinical trial, including an observed interim objective response rate of 100% for the first nine CLL patients with evaluable data receiving the recommended dosing regimen who have completed 12 weeks of cirmtuzumab plus ibrutinib treatment in Part 2.

The company continues to see a well-tolerated safety profile consistent with that seen with ibrutinib treatment alone.

In June 2019, Oncternal presented interim data from its ongoing Phase 1/2 study of cirmtuzumab in combination with ibrutinib at the 2019 American Society of Clinical Oncology annual meeting the largest oncology conference of the year.

Results from the first 12 patients with CLL treated in the Part 1 dose-finding portion of the Phase 1 study showed an observed interim ORR of 91.7% for the combination of cirmtuzumab plus ibrutinib, including three patients with clinical or confirmed complete responses, and a well-tolerated safety profile consistent with that seen for ibrutinib treatment alone.

Oncternal also disclosed at the June 2019 ASCO meeting that six patients with mantle cell lymphoma had been treated in a separate cohort of the CIRLL study.

One patient with MCL who had relapsed following an allogeneic stem cell transplant experienced a confirmed complete response after 3 months of cirmtuzumab plus ibrutinib treatment, including complete resolution of a large mediastinal mass.

This CR appears to be durable, and has been confirmed after 6, 9 and 11 months of cirmtuzumab plus ibrutinib treatment.

Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on developing a diverse pipeline of product candidates for the treatment of cancers with critical unmet medical need. Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation and progression.

The pipeline includes its lead clinical program, cirmtuzumab, a monoclonal antibody designed to inhibit the ROR1 receptor that is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL and MCL, and TK216, a small-molecule compound that is designed to inhibit E26 transformation specific family oncoproteins, which is being evaluated in a Phase 1 clinical trial alone and in combination with vincristine as a treatment for Ewing sarcoma, a rare pediatric cancer.

In addition, Oncternal has a CAR-T programme targeting ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors.